This final-form rulemaking rescinds the outdated regulations relating to emergency medical services and implements the new regulations under section 7 of Act 37. The EMS System Act repealed the Emergency Medical Services Act (prior EMS act) (35 P. S. §§ 6921—6938). The prior EMS Act was the initial statute providing for the licensing and regulation of ambulance services in this Commonwealth. With the enactment of the EMS System Act, the Commonwealth has taken a significant step in moving forward with a comprehensive Statewide emergency medical services system that is more responsive to the needs of the people of this Commonwealth. The EMS System Act is designed to achieve a higher quality, more flexible and better coordinated EMS system than that which was fostered under the prior EMS Act.

A key feature of the EMS System Act is that it includes several provisions that will enable the EMS system, without the need for further statutory amendments, to quickly adapt and evolve to meet the changing needs of the people of this Commonwealth for emergency and urgent pre-hospital and inter-facility medical care. Some of the key elements of the EMS System Act not included in the prior EMS Act are as follows:

• The scope of practice of emergency medical services (EMS) personnel closely tracks the EMS Scope of Practice Model that the National Association of State EMS Officials has developed for the National Highway Traffic Safety Administration.

• The Department is empowered to establish through regulation new types of EMS providers to meet specialized EMS needs as they are identified.

• The Department is empowered to expand the scope of practice of EMS personnel as the EMS practice model changes.

• Licenses and certifications will be permanent, subject to removal for disciplinary reasons, and continued practice will be conditioned upon a biennial or triennial registration of the license or certification and continued practice of EMS providers also will be predicated on meeting continuing education requirements or passing written and practical skills tests.

• Ambulance services, which had to meet specified staffing and vehicle requirements under the prior EMS Act, will be replaced by EMS agencies, which may have a myriad of configurations and provide different types of EMS (such as ambulance service, quick response service (QRS), wilderness EMS service and tactical EMS service). EMS agencies will be required to meet only those standards pertinent to the services they are licensed to offer.

• EMS agencies will be required to have a medical director.

• Ambulance drivers, who were not regulated under the prior EMS Act, will need to become certified and regulated. Ambulance attendants, who also were not regulated under the prior EMS Act, will be certified and regulated as emergency medical responders (EMR).

• The Department is granted emergency suspension powers to deal with an EMS provider or EMS vehicle operator who presents a clear and immediate danger to the public health and safety.

• The Department's disciplinary options are expanded to include the issuance of civil money penalties. The Department is granted jurisdiction to fine unlicensed entities that function as EMS agencies and uncertified persons who practice as EMS providers.

• The Department is empowered to enter into reciprocity agreements with other states for the certification of EMS providers.

• The Department is given the authority to enter into agreements with other states which may include, as appropriate to effectuate the purposes of the EMS System Act, the acceptance of EMS resources in other states that do not fully satisfy the requirements of the EMS System Act.

• The Department is empowered to issue conditional temporary licenses indefinitely if the Department determines it is in the public interest to do so.

• Medical command physicians, medical command facilities and medical command facility medical directors will be certified and regulated by the Department. They were not certified by the Department under the prior EMS Act.

• Physician assistants are provided a pathway, as nurses were afforded under the prior EMS Act and continue to be afforded under the EMS System Act, to become EMS providers based upon their education and experience.

• Standards are set forth as to when EMS providers are to have access to persons in need of EMS in a police incident and how police and EMS providers are to handle persons who need to be transported to a hospital for emergency medical care, but to whom the police also need access or to take into custody.

• A peer review system is established for EMS providers and physicians who direct or supervise EMS providers.

• EMS agencies are empowered to provide community-based health promotion services that are integrated into the overall health care system.

In developing this final-form rulemaking, the Department engaged the EMS community, including major stakeholder organizations, as well as other government agencies. The Department, through its Bureau of Emergency Medical Services (Bureau), conducted approximately 47 stakeholder meetings throughout this Commonwealth. The proposed rulemaking was published at 41 Pa.B. 5865 (October 29, 2011).

B. Discussion of Comments

The Department received comments from 12 different commentators, including the Independent Regulatory Review Commission (IRRC), submitting a total of 51 comments. Of the 12 commentators, 3 stated their support for the proposed rulemaking. The remaining commentators addressed various concerns with the regulations as proposed. Overall, the public response to the proposed rulemaking was positive.

In considering whether to make changes to the proposed rulemaking based upon comments received, the Department's main objectives were to ensure compliance with the EMS System Act, continue previous practices employed by the Department under the prior EMS Act and its regulation when applicable, ensure a seamless transition to the new regulations when possible and clarify the regulatory requirements for the regulated community as needed.

The Department has divided its discussion of comments received and the Department's response to comments into two parts. The first part addresses comments not specific to a particular section of the proposed rulemaking but more general in scope and application. Also included in this part are the comments the Department received that offered support for the regulations. The second part contains a discussion of comments directed at a particular section of the proposed rulemaking and a description of changes to final-form rulemaking based upon comments received and those initiated by the Department as a result of its ongoing review of the regulations.

General Comments

Comments in support of the proposed rulemaking

The Department received comments in support of the proposed rulemaking from three commentators: the Hospital Council of Western Pennsylvania; the American Heart Association, American Stroke Association (American Heart Association); and the Eastern PA EMS Council. The Hospital Council of Western Pennsylvania wanted to ''affirm its support of these changes as published in the Pennsylvania Bulletin.'' The Hospital Council of Western Pennsylvania also commented that ''we are pleased to see the relationship between pre-hospital care and in-hospital care rendered complete by these regulations.'' In a letter submitted in support of the proposed rulemaking, the American Heart Association commented that ''Specifically, we are encouraged by the emphasis on data collection and reporting that will help inform decision-makers about gaps in services, quality and outcomes to guide the future of EMS in PA.'' The Eastern PA EMS Council commented that it was ''pleased to report that we collectively support and endorse the implementation of the Emergency Medical Services System Act (Act 37) as published October 29, 2011 in the Pennsylvania Bulletin.'' The Eastern PA EMS Council also applauded the Department's efforts to engage both private and government stakeholders throughout the process, including hosting town meetings across this Commonwealth.

Comment

A commentator suggested that the Department should have an additional comment period to provide for more public input on changes that the Department makes to the rulemaking before the rulemaking becomes final. IRRC noted the commentator's suggestion in its comments.

Response

The Department considered this comment and has elected not to allow for additional public comment in response to changes to the rulemaking from proposed to final. In developing the proposed rulemaking, the Department engaged the entire EMS community, including major stakeholder organizations, which included the commentator and other government agencies. The Department, through the Bureau, conducted stakeholder meetings throughout this Commonwealth in the process of developing the regulations and has continued to engage the stakeholders as it has moved towards the adoption of this final-form rulemaking. The Bureau posted multiple drafts of the proposed rulemaking on its web site. The proposed rulemaking remained on the Bureau's web site even after the public comment period expired.

The Department utilized an open process for this rulemaking and welcomed the public's input from the very beginning. The changes that have been made to the final-form rulemaking are in response to public comments, comments from IRRC and as a result of the Department's ongoing review of the regulations. There has been considerable discussion both prior to and after publication of the proposed rulemaking. The need for implementation of the regulations, as urged by the regulated community, outweighs the need for further public discussion.

Comment

A commentator expressed the concern that the EMS System Act does not permit EMS providers who are sanctioned by individual EMS agency medical directors to request administrative review of the sanction imposed.

Response

The EMS System Act did not retain the appeal process in the prior EMS Act permitting a sanctioned EMS provider to request administrative review of the EMS agency medical director's decision. The Department supports the elimination of the appeal provision. Under the prior EMS Act, a paramedic or prehospital registered nurse (PHRN) could appeal the decision of an advanced life support (ALS) service medical director who withdrew or denied medical command authorization to the regional EMS medical director for the ALS service. See section 11(d)(2)(iv) and (e.1)(4) of the prior EMS Act (35 P. S. § 6931(d)(2)(iv) and (e.1)(4)). If the paramedic or PHRN was unhappy with the decision of the regional EMS medical director, he could appeal to the Department and then to Commonwealth Court. See former § 1003.28. The appeal provision was not included in the EMS System Act. When the General Assembly deletes statutory language, it is presumed that the General Assembly intended to make that language inoperative. Therefore, medical command authorization decisions may not be appealed to the regional EMS medical director and the Department. Even though administrative review of medical command authorization decisions has been eliminated, an EMS provider whose medical command authorization is denied or withdrawn may file a civil action in a court of competent jurisdiction.

Under the prior EMS Act, from 2005 to 2012, the Department decided fewer than five medical command authorization appeals. Even with a limited number of appeals, however, there were increasing concerns surrounding the administrative appeal process. Primary among them was whether the Department could, or should, substitute its judgment for that of the ALS service medical director. Another concern was whether the Department should be inserted in a conflict between an employer (the ambulance service) and an employee (the paramedic or PHRN) or dictate to the employer how the conflict should be resolved. For many reasons, it makes sense to remove the Department from this process.

IRRC comment—Intent of the General Assembly

IRRC noted that in the Regulatory Analysis Form (RAF) submitted with the rulemaking the Department identified sections of the EMS System Act that provide the Department with both general and specific statutory authority to promulgate the final-form rulemaking. IRRC noted, however, that those sections of the EMS System Act are not cross referenced to the specific sections of the regulations promulgated based upon that authority. IRRC requested that the Department identify the specific sections of the EMS System Act that correlate to specific sections of the regulations to assist IRRC in determining if the regulations are consistent with the intent of the General Assembly.

Response

Following is a brief explanation of the general and specific statutory authority granted to the Department to promulgate the final-form rulemaking and a chart that lists each regulatory section, in order, with the corresponding statutory section that provides the Department with authority to promulgate the particular section of the final-form rulemaking.

Section 7 of Act 37

Section 7 of Act 37 provides that the EMS System Act shall be liberally construed to authorize the Department to promulgate regulations to carry out the provisions of the EMS System Act and states that the absence of express authority to adopt regulations in a provision of the EMS System Act may not be construed to preclude the Department from adopting a regulation to carry out that provision.

Section 8103 of the EMS System Act

Section 8103 of the EMS System Act (relating to definitions) defines several terms in a manner that expressly permit the Department to expand the definition by regulation. The term ''emergency medical services agency'' or ''EMS agency'' is defined as an entity that may provide EMS through the operation of certain types of services and the deployment of certain vehicles, which are listed in the definition. The definition also provides that the Department may expand the list of services and vehicles through regulation. Final-form § 1027.37 (relating to intermediate advanced life support squad service) is promulgated based upon this statutory authority.

The definition of ''emergency medical services provider'' or ''EMS provider'' identifies the different types of EMS providers certified by the Department. This definition also empowers the Department to establish by regulation other types of EMS providers to provide specialized EMS. This authority is also addressed in section 8113(a) of the EMS System Act (relating to emergency medical services providers). The Department established different types of rescue personnel under § 1023.52 (relating to rescue personnel) under section 8113(a)(8) of the EMS System Act.

Section 8105 of the EMS System Act

Section 8105 of the EMS System Act (relating to duties of department) includes language permitting the Department to adopt regulations. Section 8105(b)(2) of the EMS System Act authorizes the Department to establish by regulation standards and criteria governing the awarding and administration of contracts and grants by the Department for the initiation, maintenance and improvement of regional EMS systems through the Emergency Medical Services Operating Fund (EMSOF). Sections 1021.21—1021.28 (relating to award and administration of EMSOF funding) are promulgated based upon this statutory authority.

Section 8105(b)(4) of the EMS System Act empowers the Department to collect, as deemed necessary and appropriate, data and information regarding patients who utilize emergency departments without being admitted to the facility and patients admitted through emergency departments, trauma centers or directly to special care units in a manner that protects and maintains the confidential nature of patient records. The data and information collected is to be reasonable in detail and is to be collected under regulations issued by the Department. Sections 1021.8, 1021.64 and 1021.141 (relating to EMS data collection; cooperation; and research) are promulgated under this statutory authority.

Section 8105(b)(11) of the EMS System Act authorizes the Department to promulgate regulations to establish standards and criteria for EMS systems. Sections 1027.31, 1029.21, 1031.2 and 1033.1—1033.7 are promulgated under this statutory authority.

Section 8106 of the EMS System Act

Section 8106(d) of the EMS System Act (relating to emergency medical services patient care reports) provides that an EMS agency shall report to the Department or a regional EMS council, as directed by Department regulation, information from EMS patient care reports (PCR) solicited through the reporting process. In addition, section 8106(a) of the EMS System Act requires an EMS agency to ensure that its responding EMS providers complete an EMS PCR for each response made in which it encounters a patient or a person who has been identified as a patient to the EMS agency, unless the Department, by regulation, exempts certain types of patient contact from the reporting requirement. Sections 1021.41—1021.43 (relating to EMS patient care reports; dissemination of information; and vendors of EMS patient care reports) are promulgated under this statutory authority.

Section 8113 of the EMS System Act

Section 8113 of the EMS System Act contains numerous provisions that grant the Department authority to promulgate regulations. Section 8113(a)(8) of the EMS System Act provides the Department authority to establish new types of EMS providers by regulation. Section 1023.52 is promulgated under this statutory authority.

Section 8113(c) of the EMS System Act provides the Department with authority to create an application process for EMS provider applicants. This section further provides that the Department may do so by creating paper application forms or by establishing an electronic application process. Section 1023.21 (relating to general rights and responsibilities) is promulgated under this statutory authority.

Section 8113(d)(1) and (2) of the EMS System Act requires the Department to develop standards through regulations for the accreditation and reaccreditation of EMS educational institutes and for the approval of continuing education courses and the accreditation of entities that provide continuing education courses. Sections 1023.31, 1023.32, 1025.1—1025.3, 1025.21—1025.23, 1031.12 and 1031.13 are promulgated under this statutory authority.

Section 8113(e) of the EMS System Act establishes standards for taking and passing EMS provider certification examinations. Section 8113(e)(7) of the EMS System Act permits the Department to change those standards through regulation. The Department has opted not to change those standards at this time.

Sections 8114—8120 of the EMS System Act

Sections 8114—8120 of the EMS System Act address scope of practice, certification and registration requirements for EMS providers. The provisions addressing scope of practice permit the EMS provider to function beyond the scope of practice as authorized by Department regulation. See sections 8114(a)(3), 8115(a)(3) and (4), 8116(a)(3) and (4), 8117(a)(3) and (4), 8118(a)(3) and (4), 8119(a)(3) and (4) and 8120(a)(3) and (4) of the EMS System Act. Sections 1023.24(a)(3), 1023.25(a)(3), 1023.26(a)(3), 1023.27(a)(3), 1023.28(a)(3), 1023.29(a)(3) and 1023.30(a)(3), permitting the EMS provider specified to operate as a member of a special operations EMS service, are promulgated under this statutory authority.

An EMS provider needs both a certification and a current registration of that certification to practice. Sections 8114—8120 of the EMS System Act provide that the application for registration of an EMS provider certification is to be submitted using a form or an electronic process prescribed by the Department by regulation. These sections also provide that when the registration has expired and the EMS provider subsequently seeks to register the certification, the EMS provider may secure a current registration of the provider's certification by qualifying for the registration under requirements established by the Department by regulation. Section 1023.21(e) is promulgated under this statutory authority.

To ensure that there is not an unintentional lapse in the registration of an EMS provider certification, sections 8114—8120 of the EMS System Act provide that the registration applications are to be submitted at least 30 days prior to when they are to expire or within a lesser time before their expiration if permitted by Department regulation. See sections 8114(c)(1)(i)(B) and (2); 8115(c)(1)(i)(B) and (2); 8116(c), (c)(1)(i)(B) and (2); 8117(d), (d)(1)(i)(B) and (2); 8118(c), (c)(1)(i)(B) and (2); 8119(c), (c)(1)(i)(B) and (2); and 8120(c)(1)(i) and (2) of the EMS System Act. The Department elected not to change the application time frame for EMS provider registration through regulation at this time.

Sections 8116 and 8117 of the EMS System Act (relating to advanced emergency medical technicians; and paramedics) also give the Department authority to promulgate regulations containing the requirements that an advanced emergency medical technician (AEMT) or paramedic shall meet to become certified. Specifically, section 8116 of the EMS System Act requires an AEMT to complete an AEMT training course that teaches ALS skills deemed appropriate by regulation of the Department. Section 8117(c)(2)(ii) of the EMS System Act requires that an emergency medical technician (EMT) or AEMT who wishes to become certified as a paramedic successfully complete a paramedic training course that teaches ALS skills deemed appropriate by regulation of the Department. Sections 1023.26(b)(1)(iii) and 1023.27(b)(5) (relating to advanced emergency medical technician; and paramedic) are promulgated under this statutory authority.

Section 8122 of the EMS System Act

Section 8122 of the EMS System Act (relating to emergency medical services vehicle operators) is similar to sections 8113—8120 of the EMS System Act in that it authorizes the use of regulations to prescribe the manner in which applications for an emergency medical services vehicle operator's (EMSVO) certification and registration of the certification are to be submitted and the requirements for registering a certification after the registration has expired. See section 8122(b)(1)(ii) and (4) of the EMS System Act. Section 1023.22(d) (relating to EMS vehicle operator) is promulgated under this statutory authority.

Section 8124 of the EMS System Act

Section 8124 of the EMS System Act (relating to emergency medical services instructors) addresses requirements for individuals who wish to become certified as EMS instructors. Section 8124(a)(1) and (b)(1)(i) and (2) of the EMS System Act addresses the application and certification procedures for EMS instructors and gives the Department authority to promulgate regulations regarding the application and certification process for EMS instructors. In addition, section 8124(c) of the EMS System Act provides that the Department may adopt regulations to set standards for EMS instructors providing instruction in EMS educational institutes. Section 1023.51 (relating to certified EMS instructors) is promulgated under this statutory authority.

Section 8125 of the EMS System Act

Section 8125(b) of the EMS System Act (relating to medical director of emergency medical services agency) prescribes the roles and responsibilities of an EMS agency medical director. Section 8125(b)(9) of the EMS System Act provides that the EMS agency medical director is to perform other functions the Department imposes by regulation. Section 1023.1(a)(1)(ii), (viii), (ix) and (4) (relating to EMS agency medical director) is promulgated under this statutory authority.

Section 8126 of the EMS System Act

Section 8126(c) and (g) of the EMS System Act (relating to medical command physicians and facility medical directors) requires registration of the certification for a medical command physician and a medical command facility medical director to be submitted through a form or an electronic process as prescribed by the Department by regulation. This section also permits the Department to impose other conditions regarding registration of certification by regulation. Sections 1023.2(c) and 1023.3(c) (relating to medical command physician; and medical command facility medical director) are promulgated under this statutory authority.

Section 8127 of the EMS System Act

Section 8127(d) of the EMS System Act (relating to medical command facilities) permits the Department to promulgate regulations to ensure a medical command facility operates in an effective and efficient manner to achieve the purposes for which it is certified. Moreover, section 8127(c) of the EMS System Act requires medical command facilities to: be a distinct medical unit operated by a hospital or consortium of hospitals; possess the necessary equipment and personnel for providing medical command to, and control over, EMS providers; employ a medical command facility medical director; take measures necessary to ensure that a medical command physician is available to provide medical command at all times; and meet the communication, recordkeeping and other requirements of the Department. Sections 1029.1—1029.6 (relating to medical command facilities) are promulgated under the statutory authority in section 8127(c) and (d) of the EMS System Act.

Section 8128 of the EMS System Act

Section 8128(b) of the EMS System Act (relating to receiving facilities) specifies requirements that a facility shall satisfy to qualify to receive patients transported by ambulance. It also includes a provision that empowers the Department, through regulation, to authorize other types of facilities to serve as receiving facilities for purposes of serving patients who have special medical needs. The Department elected not to authorize other types of facilities to serve as receiving facilities for purposes of serving patients who have special medical needs at this time.

Sections 8129—8137 of the EMS System Act

Section 8129 of the EMS System Act (relating to emergency medical services agencies) provides that an entity may not operate an EMS agency unless it holds an EMS agency license. It also specifies the various vehicles and services that an EMS agency may operate and authorizes the Department to establish by regulation other vehicles or services requiring licensure. Final-form § 1027.37 and § 1027.42 (relating to water ambulance service) are promulgated under this statutory authority.

Section 8129(c)(5) of the EMS System Act provides that the Department may establish by regulation criteria that an applicant for an EMS agency license shall demonstrate that its EMS agency medical director satisfies, depending upon the types of EMS vehicles the applicant is applying to operate and the types of EMS services it is applying to provide. Section 1027.1(b)(5) (relating to general provisions) is promulgated under this statutory authority.

Section 8129(f)(1) of the EMS System Act permits an EMS agency to enter into a contract with another entity to manage the EMS agency, but requires that an entity that provides management services for an EMS agency be approved by the Department. One of the requirements for approval is that the entity be in compliance with the Department's regulations. Section 1027.14 (relating to management companies) is promulgated under this statutory authority.

Section 8129(g) of the EMS System Act requires certain types of EMS vehicles to display a Department-issued inspection sticker as prescribed by the Department by regulation. Section 8129(g) of the EMS System Act further provides that the Department may require, by regulation, other types of EMS vehicles to display a Department-issued inspection sticker. Section 1027.7(a), (b), (d) and (e) (relating to EMS vehicle fleet) is promulgated under this statutory authority.

Section 8129(i)(2) of the EMS System Act provides that if an EMS agency operates a communications center that dispatches EMS resources, the center will be viewed as part of the EMS agency's licensed operation and subject to the Department's regulations. Final-form § 1027.4 (relating to EMS agency dispatch centers) is promulgated under this statutory authority.

Section 8129(l) of the EMS System Act permits the Department to revise by regulation the staffing standards for the various types of EMS vehicles that EMS agencies may operate under sections 8130—8135 of the EMS System Act. The Department changed the staffing standards for basic life support (BLS) ambulance services in § 1027.33 (relating to basic life support ambulance service) and ALS ambulance services in final-form § 1027.35 (relating to advanced life support ambulance service).

Section 8129(p) of the EMS System Act requires the Department to promulgate regulations imposing additional requirements on EMS agencies based upon the types of EMS vehicles they operate and the services they provide. Sections 1027.1—1027.14 and 1027.31—1027.42 (relating to general requirements; and EMS agency services) are promulgated under this statutory authority.

Section 8136 of the EMS System Act

Section 8136 of the EMS System Act (relating to special operations emergency medical services) addresses special operations EMS services that possess specialized knowledge, equipment or vehicles to access a patient or address a patient's emergency medical needs.

Section 8136(a) of the EMS System Act requires the Department, by regulation, to provide for specific types of special operations EMS teams. Section 1027.41 (relating to special operations EMS services) is promulgated under this statutory authority.

Section 8136(b) of the EMS System Act permits the Department to prescribe by regulation additional training and expertise requirements for the EMS agency medical director and the EMS providers who staff a special operations EMS service. Section 1027.41(b) is promulgated under this statutory authority.

Section 8136(c) of the EMS System Act permits the Department to promulgate regulations to establish staffing, equipment, supplies and other requirements for a special operations EMS service. Section 1027.41 is promulgated under this statutory authority.

Section 8136(d) of the EMS System Act addresses entities that apply to operate special operations EMS services that the Department has not provided for in regulations. Section 8136(d) of the EMS System Act states that the Department will evaluate the merits of each application on an individual basis and may conditionally grant or deny an application based upon considerations of public health and safety. This section further states that the grant of an application will be subject to compliance with later-adopted regulations addressing that type of special operations EMS service. The Department will evaluate on an ongoing basis the need for additional regulations to ensure appropriate regulatory guidance for special operations EMS services operating in this Commonwealth.

Section 8138 of the EMS System Act

Section 8138 of the EMS System Act (relating to other vehicles and services) authorizes the Department to promulgate regulations to establish EMS vehicle and service standards for EMS vehicles and services not specified in the EMS System Act. Final-form §§ 1027.34 and 1027.39 (relating to intermediate advanced life support ambulance service; and critical care transport ambulance service) and final-form § 1027.37 are promulgated in part under this statutory authority.

The authority to promulgate each section of the final-form rulemaking is provided in the following chart with the section of the regulation and the corresponding section or sections of the EMS System Act, or other act as applicable, giving the Department authority to promulgate the section:

IRRC noted that the EMS System Act permits the Department to publish in the Pennsylvania Bulletin changes to EMS PCRs (section 8106(f) of the EMS System Act), skills within the scope of practice of each type of EMS provider (section 8113(g) of the EMS System Act) and vehicle construction and equipment and supply requirements for EMS agencies (section 8129(j) of the EMS System Act). IRRC listed the following sections that permit publication of information pertinent to the regulation in the Pennsylvania Bulletin. The Department grouped these sections into seven categories.

IRRC commented that it has three concerns regarding the use of the Pennsylvania Bulletin to publish information pertinent to these regulations. IRRC inquired how use of publication in the Pennsylvania Bulletin, as described in each of the sections previously listed, is consistent with the EMS System Act. IRRC also inquired how the regulated community can reasonably comply; that is, how the regulated community will know whether the requirements in these regulations are amended and how the regulated community will find those specific documents in the Pennsylvania Bulletin. IRRC noted that this task for the regulated community will become more complicated with subsequent publications in the Pennsylvania Bulletin. IRRC inquired how the Department will implement provisions that can be altered by publication in the Pennsylvania Bulletin. IRRC asked whether the Department will consider placing on its web site a compendium of changes that it publishes in the Pennsylvania Bulletin after the effective date of these regulations.

Response

The Department will provide the statutory authority for each of the sections previously listed that incorporate use of publication in the Pennsylvania Bulletin to inform the regulated community of information needed to comply with the regulation. First, however, the Department will address the basis, generally, for use of the Pennsylvania Bulletin in connection with this Commonwealth's EMS system. The General Assembly, in enacting the EMS System Act, recognized the need for an EMS system that is able to evolve to meet the needs of the residents of this Commonwealth. Section 8102 of the EMS System Act (relating to declaration of policy) states the following:

* * * * *

(5) It serves the public interest if the emergency medical services system is able to quickly adapt and evolve to meet the needs of the residents of thisCommonwealth for emergency and urgent medical care and to reduce their illness and injury risks.

* * * * *

(8) This chapter shall be liberally construed to establish and maintain an effective and efficient emergency medical services system which is accessible on a uniform basis to residents of this Commonwealth and to visitors to this Commonwealth.

* * * * *

(10) The Department of Health should continually assess and, as needed, revise the functions of emergency medical services agencies and providers and other components of the emergency medical services system that it regulates under this chapter to:

(i) improve the quality of emergency medical services provided in this Commonwealth;

(ii) have the emergency medical services system adapt to changing needs of the residents of this Commonwealth; and

(iii) promote the recruitment and retention of persons willing and qualified to serve as emergency medical services providers in this Commonwealth.

* * * * *

Although specifically provided for in the EMS System Act, use of publication in the Pennsylvania Bulletin is not new. The Department has been using the Pennsylvania Bulletin to make announcements and effectuate changes for a significant amount of time. For example, since the first EMS regulations were promulgated in 1989 under the prior EMS Act, the Department has published notices in the Pennsylvania Bulletin listing approved medications that may be used by paramedics and listing EMSOF funding priorities. See former §§ 1001.23(b) and 1003.24(a)(2)(v)) as published at 19 Pa.B. 2843 (July 1, 1989). Since the regulations were revised in 2000 under the prior EMS Act, the Department has published notices in the Pennsylvania Bulletin regarding information required to be included in EMS PCRs, changes in scope of practice for EMS providers, required ground and air equipment and supplies and QRS program recognition requirements. See former §§ 1001.41(a), 1003.23(f)(1), 1003.24(e)(1), 1005.10(c)(1), 1007.7(c) and 1015.1(a)(1) as published at 30 Pa.B. 5363 (October 14, 2000).

The regulated community is accustomed to announcements and notices published in the Pennsylvania Bulletin, a practice that has been ongoing for a majority of announcements for at least 10 years, and with regard to two types of announcements, for over 20 years. Publication of notices in the Pennsylvania Bulletin is the most effective way to address the ever-changing nature of EMS in this Commonwealth. If the Department were unable to utilize the Pennsylvania Bulletin to notify the regulated community regarding essential information, the Department could not quickly and efficiently address issues concerning this Commonwealth's EMS system. These notices are, and will be, available on the Bureau's web site, the Pennsylvania Bulletin's web site, and from regional EMS councils and the Board of Directors of the Pennsylvania Emergency Health Services Council (Advisory Board).

Use of the Pennsylvania Bulletin regarding EMSOF

Section 8153 of the EMS System Act (relating to support of emergency medical services) carries over a provision from the prior EMS Act that established an EMSOF special fund to support EMS throughout this Commonwealth. EMSOF funds are to be used by a regional EMS council to plan, initiate, maintain, expand or improve a regional EMS system in a manner that is consistent with the Statewide and relevant regional EMS system plans. Under section 8112 of the EMS System Act (relating to contracts and grants), the Department is tasked with distributing EMSOF funding; therefore, the Department must make decisions each year as to funding priorities. The notice in the Pennsylvania Bulletin, listing funding priorities, is merely informational in nature. These priorities are not binding on regional EMS councils. Notice in the Pennsylvania Bulletin of funding priorities alerts regional EMS councils to areas of this Commonwealth's EMS system targeted for improvement through the process described as follows.

Each year, regional EMS councils are required to submit reports to the Department per the terms of their grant agreements with the Department. As part of these reports, regional EMS councils are required to inform the Department of any new or existing issues that may require the Department's attention. Through these reports, the Department gains an understanding of possible shortcomings in this Commonwealth's EMS system. The Department uses notices in the Pennsylvania Bulletin to inform the EMS community, and the public at large, of the Department's funding priorities for limited EMSOF funds. Notwithstanding notice of funding priorities, recipients of EMSOF funding are free to use the funds awarded to enhance local EMS needs, provided they use the EMSOF funds under the criteria in the EMS System Act, specifically sections 8112 and 8153 of the EMS System Act, and the Department's regulations.

Sections 1021.24(b) and (e) and 1021.25(10) (relating to use of EMSOF funding by a regional EMS council; and allocation of EMSOF funds to regional EMS councils) permit the Department to publish in the Pennsylvania Bulletin notices concerning EMSOF funding. Section 1021.24(b) permits the Department to use the Pennsylvania Bulletin to set forth additional priorities for funding on a yearly basis. EMSOF funding priorities change depending on the state of the Commonwealth's EMS system in a given year and the amount of funding available. Section 1021.24(e) permits the Department to use the Pennsylvania Bulletin to establish the percentage of matching funds, as compared to the total funds received, that entities applying for grants must provide as a condition of receiving EMSOF funding. Matching funds also are required for grants to regional EMS councils and are necessary due to the limited funding available. Section 1021.25(10) permits the Department to publish in the Pennsylvania Bulletin other factors the Department will consider in determining the amount of EMSOF funding a regional EMS council may receive to distribute to requesting entities.

Use of the Pennsylvania Bulletin in connection with EMS PCRs

Before an EMS agency departs from a receiving facility to which it has transported a patient, it is required to give certain essential information to the receiving facility so that the receiving facility is apprised of the patient's condition. Section 8106 of the EMS System Act gives the Department authority to create a form or other reporting process for use by EMS agencies for each EMS response. Section 8106(f) of the EMS System Act requires a vendor, proposing to modify the form or software marketed as appropriate for use by EMS agencies in making PCRs, to submit the modifications to the Department for review and approval. The same section requires approved modifications to be published in the Pennsylvania Bulletin with an effective date no sooner than 60 days following publication. Section 1021.43(c) is promulgated under this authority.

Sections 1021.41(a) and (c), 1021.43(c) and 1027.41(b)(2)(i) permit the Department to publish notices in the Pennsylvania Bulletin regarding EMS PCRs. Section 1021.41(a) permits the Department to use the Pennsylvania Bulletin to publish a list of the data elements and the form specifications that must be a part of an EMS PCR form. Form specifications are required to ensure that patient care information is uniform across this Commonwealth. Using this mechanism, the Department will be able to make changes to ensure better guidance for EMS providers and more information for hospitals and other receiving facilities who receive patients. Better and more accurate forms will benefit the health care community at large and the patients that seek health care services. Health care providers, including EMS providers, will be better informed regarding the patient's condition, leading to better decision making for treatment. Section 1021.41(c) addresses the Department's use of the Pennsylvania Bulletin in publishing a notice that specifies the types of patient information that the Department deems essential for patient care.

Special operations EMS is a distinct type of EMS, as it operates in certain environments where specialized knowledge and skills are required. Therefore, the standard EMS PCR form is often not sufficient for these types of EMS services. Section 1027.41(b)(2)(i) permits the Department to use the Pennsylvania Bulletin to provide notice to special operations EMS services regarding the information they must gather for each patient they encounter.

Use of the Pennsylvania Bulletin regarding scope of practice of EMS providers

Section 8113(g) of the EMS System Act permits the Department to publish in the Pennsylvania Bulletin a list of skills within the scope of practice of each type of EMS provider. EMS providers, as listed in the EMS System Act, include EMRs, EMTs, AEMTs and paramedics. See the definition of ''emergency medical services provider'' in section 8103 of the EMS System Act.

Sections 1023.24(d)(1)—(3) and 1023.25(d)—(3) (relating to emergency medical responder; and emergency medical technician) and §§ 1023.26(d)(1)—(3) and 1023.27(d)(1)—(3) permit the Department to publish notices in the Pennsylvania Bulletin concerning the scope of practice of each EMS provider.

Sections 1023.24(d)(1), 1023.25(d)(1), 1023.26(d)(1) and 1023.27(d)(1) state that the Department will publish in the Pennsylvania Bulletin the skills included within the scope of practice for the EMS provider identified in the regulation.

Sections 1023.24(d)(2), 1023.25(d)(2), 1023.26(d)(2) and 1023.27(d)(2) state that the Department will publish a notice in the Pennsylvania Bulletin when the scope of practice of the EMS provider may be expanded, as permitted by section 8113(g) of the EMS System Act.

Sections 1023.24(d)(3), 1023.25(d)(3), 1023.26(d)(3) and 1023.27(d)(3) state that the Department will publish in the Pennsylvania Bulletin the frequency with which the Department will publish the list of skills within the scope of practice of the EMS provider as permitted by section 8113(g) of the EMS System Act.

Use of the Pennsylvania Bulletin regarding continuing education

Section 8122(b) of the EMS System Act gives the Department the authority to identify continuing education requirements for EMSVOs. Section 1023.31(a) (relating to continuing education requirements) states that the Department will use the Pennsylvania Bulletin to publish a notice regarding continuing education requirements for EMSVOs on a 3-year renewal cycle, who need to complete three continuing education credits, and EMSVOs on a 2-year renewal cycle, who need to complete two continuing education credits.

Sections 8105(b)(6) and 8113(d) of the EMS System Act give the Department authority, generally, to identify the educational requirements for EMS providers. Further, the EMS System Act mandates that each type of EMS provider shall complete continuing education credits as required by the Department in continuing education programs approved by the Department. See sections 8114(c)(1)(ii)(B), 8115(c)(1)(ii)(B), 8116(c)(1)(ii)(B), 8117(d)(1)(ii), 8118(c)(1)(iii), 8119(c)(1)(iii), 8120(c)(1)(iii) and 8122(b)(1)(iv) of the EMS System Act. These provisions of the EMS System Act give the Department the authority to set continuing education requirements, including the number of credits each EMS provider shall secure and the types of courses EMS providers may take, to satisfy those credits.

This section states that the Department will publish in the Pennsylvania Bulletin a notice regarding the types of instruction that each EMS provider type shall receive to satisfy continuing education requirements. Each EMS provider will be required to complete a certain amount of continuing education credits in clinical patient care and other core continuing education courses.

The number of credits required for each type of EMS provider is set by regulation and the Department will not change that number through notices published in the Pennsylvania Bulletin. However, as an EMS provider's scope of practice changes, and this Commonwealth's EMS system evolves through advancements in technology, equipment and supplies, the Department will need the flexibility to specify the subject matter areas or courses meeting requirements for the continuing education credits for each type of EMS provider.

Use of the Pennsylvania Bulletin regarding reciprocity

Section 8113(f)(1) of the EMS System Act gives the Department authority to enter into reciprocity agreements with other states' EMS certifying agencies. These reciprocity agreements will enable the Department to recognize EMS certifications from other states that the Department considers having substantially similar requirements for EMS certification in this Commonwealth.

Section 1023.34(b) (relating to reciprocity) addresses publication of notices by the Department in the Pennsylvania Bulletin listing the states in which it has entered into a reciprocity agreement and, for each state, the type of EMS provider covered by the reciprocity agreement. The Department will use publication in the Pennsylvania Bulletin to provide notice to the regulated community and out-of-State EMS providers regarding the certifications the Department will recognize through reciprocity.

Use of the Pennsylvania Bulletin regarding EMS agencies

Section 8129(j) of the EMS System Act gives the Department authority to use the Pennsylvania Bulletin to publish vehicle construction and equipment and supply requirements for EMS agencies based upon the types of EMS vehicles the EMS agency operates and the services it provides. The section also gives the Department authority to update the notice in the Pennsylvania Bulletin as necessary.

Section 1027.3(c) (relating to licensure and general operating standards) and §§ 1027.1(b)(6) and 1027.7(c) notify EMS agencies that they will be required to abide by notices in the Pennsylvania Bulletin concerning EMS vehicles, equipment and supplies. Section 1027.5(b) (relating to medication use, control and security) states that the Department will publish in the Pennsylvania Bulletin notices concerning medications that may be used by each type of EMS provider and the types of medication that each type of EMS agency shall have in stock. The notice will also list the medications that may be used by these EMS providers who are authorized to administer medications to patients. As advancements in medications occur, medications authorized for use by these EMS providers will change. Medications also may be removed from the list.

Section 1027.40(f) (relating to air ambulance service) and §§ 1027.39(d) and 1027.41(b)(1) address the skills practiced and equipment used by EMS providers when providing EMS through a critical care transport ambulance service, an air ambulance service or a special operations EMS service. As these types of EMS services require EMS providers with unique and specialized knowledge and training for specific types of patients and events, they will be expected to use skills beyond their standard scopes of practice. The EMS providers staffing these services will be required to complete training for an expanded scope of practice. The Department will publish in the Pennsylvania Bulletin notice of the additional equipment and skills that may be used by a properly trained EMS provider with an expanded scope of practice.

As emergency medical services evolve, new and better types of equipment and supplies will be introduced that will enable EMS providers to perform their jobs more effectively. As technology advances, vehicle construction specifications for ambulances and other types of EMS vehicles will be updated. Through publication in the Pennsylvania Bulletin, the Department will be able to put these advancements into place quickly. With better equipment, better supplies and updated vehicle specifications, EMS agencies and providers will be able to better serve the citizens of this Commonwealth.

Use of the Pennsylvania Bulletin regarding specialty receiving facilities

Proposed § 1029.21(b) (relating to receiving facilities) stated that the Department would publish in the Pennsylvania Bulletin a list of specialty receiving facilities in the areas of trauma, percutaneous coronary intervention, acute strokes, serious burns and other receiving facilities for other patients with special needs as described in the Statewide EMS protocols. This proposed subsection was based on section 8128(b) of the EMS System Act that authorizes the Department to designate facilities by regulation, in addition to those specifically listed in section 8128(b) of the EMS System Act, to serve as receiving facilities for purposes of serving patients who have special medical needs.

After much consideration, the Department decided to revise § 1029.21(b) permitting designation of types of receiving facilities. The Department deleted language in § 1029.21(b) regarding notices it would publish in the Pennsylvania Bulletin designating specialty receiving facilities for trauma centers patients, percutaneous coronary intervention patients, acute stroke patients, serious burn patients and other receiving facilities appropriate for other patients with special needs as described in the Statewide EMS protocols. Language in § 1029.21(b) addressing the manner in which EMS providers transport patients to receiving facilities under Statewide EMS protocols remains in the final-form rulemaking. The Department will continue to discuss issues surrounding specialty receiving facilities and will, if need be, reintroduce this concept in a future rulemaking.

Use of the Pennsylvania Bulletin and compliance by the regulated community

IRRC requested that the Department explain how the regulated community will know: (1) whether the requirements in the regulations have been amended; (2) how to find those specific publications in the Pennsylvania Bulletin; and (3) how the Department will implement changes published in the Pennsylvania Bulletin and whether the Department has considered placing changes on its web site.

Response

Publication in the Pennsylvania Bulletin of information such as courses that will satisfy continuing education requirements, scope of practice, approved medications, equipment, supplies, EMS PCR changes and reciprocity does not equate to amendment or revision of a regulation. Information that the Department will publish in the Pennsylvania Bulletin will enable compliance with the regulatory requirement. EMS providers will have a resource available to them, in the form of Department notices, when reviewing continuing education courses and deciding whether the courses offered will satisfy their requirements for certification and registration.

Since the first EMS regulations were promulgated in 1989, the Department has published notices in the Pennsylvania Bulletin listing approved medications that may be used by paramedics. See former § 1003.24(a)(2)(v) as published at 19 Pa.B. 2858. In situations when there is a drug shortage, the Bureau has updated the drug list by publishing a notice in the Pennsylvania Bulletin which replaces the drug that is in short supply with another drug that is more readily available. By using the Pennsylvania Bulletin, the Bureau was able to react quickly to protect the lives of the patients that EMS providers encounter. The Department has been publishing notices in the Pennsylvania Bulletin concerning the scope of practice for each type of EMS provider since 2000. See 30 Pa.B. 5363. In 2011, the Department revised the scope of practice notice by removing medical anti-shock trousers as an approved treatment, adding transport ventilators for use by ALS providers and carbon monoxide co-oximetry monitoring for EMS providers. See 41 Pa.B. 1976 (April 9, 2011). The Department has been publishing notices regarding required ground and air ambulance equipment and supplies since 2000. In 2011, the Department published a notice in the Pennsylvania Bulletin requiring ambulances to have a minimum of two 5-pound unit fire extinguishers to help combat fire-related issues. See 41 Pa.B. 2296 (April 30, 2011).

When the Department prepares to publish a notice in the Pennsylvania Bulletin, it first sends out a draft notice to regional EMS councils for their feedback and comments. After reviewing comments from regional EMS councils, the Bureau makes appropriate revisions. The Bureau then sends an advance copy of the notice to regional EMS councils and the Advisory Board prior to publication in the Pennsylvania Bulletin. When regional EMS councils receive the notice, they post the notice on their web sites and also send the notice to the EMS agencies under their jurisdiction. The Advisory Board also publishes the notice. The Department publishes the notice in the Pennsylvania Bulletin and also posts the notice on the Bureau's web site. The Department has used this approach for many years without complaints from the regulated community regarding a lack of advance notice. Since EMS agencies and providers receive advance notice from regional EMS councils prior to publication of the notice in the Pennsylvania Bulletin, EMS agencies and providers are aware of, and can prepare for, upcoming changes. The Bureau ensures that notices are readily available in one place on its web site should interested persons need to review them. Interested persons can access notices by clicking on the link on the Bureau's web site entitled ''EMS regulations.'' That link will take the person to the Bureau's webpage that provides access to the EMS regulations and the notices that the Bureau publishes as they are updated.

In addition, in the notices published in the Pennsylvania Bulletin, the Bureau, when practical, will highlight changes to information included in the announcement as compared to information in the previous announcement. By way of example, when the Bureau published its notice at 42 Pa.B. 4229 (July 7, 2012) listing approved drugs for ALS ambulance services, the Bureau identified the changes to the list since the list was last published at 41 Pa.B. 2286 (April 30, 2011).

IRRC comment—Economic impact of the regulations

IRRC commented on the Department's responses to questions 17-20 of the RAF as part of the proposed rulemaking package. IRRC asked the Department to review these responses and, to the best of its ability, provide dollar estimates of the costs or savings, or both, associated with implementation of the regulations.

Response

For the final-form rulemaking package, the Department used an updated RAF form and the item numbers in the updated form that IRRC questioned are the following: (19) cost or savings to the regulated community; (20) costs or savings to local governments; (21) cost or savings to the State government; and (23) the fiscal table.

The EMS System Act and the regulations require that EMS agencies have a medical director. The Department anticipates that there will be little economic impact as a result of this requirement because a majority of EMS agencies in this Commonwealth already have a medical director. For approximately the past decade, since the introduction of automatic external defibrillators (AED) at the BLS level in prehospital care, EMS agencies that carried AEDs on their ambulances have been required to have a medical director and, in 2011, ambulances were required to have AEDs. The reason to require a medical director for AED service is to ensure the medical review of the emergency response when the AED unit is placed on a patient.

Therefore, ALS EMS agencies and about 80% of BLS EMS agencies currently have a medical director. Payment for medical directors varies across this Commonwealth. Most medical directors serve as volunteers, although some medical directors are paid a salary or perform services by means of a contract. Since it is up to EMS agencies to determine what level of involvement they want their EMS agency medical directors to have, the time commitment for the medical director will vary as will the cost to employ the medical director.

The Department has not had, and will not have, a role in approving medical directors or their salaries. Based on information the Department has received from regional EMS councils, the majority of EMS agencies have volunteer agency medical directors and a majority of the EMS agencies that contract for medical directors have part-time medical directors that are paid $50 to $85 per hour for approximately 10 to 20 hours of work per month. While a top-salaried medical director earns approximately $130,000 per year, that medical director has job duties in addition to those of a medical director. These figures have been added to the fiscal table in the RAF.

The Pennsylvania Chapter of the American College of Emergency Physicians offered assistance to regional EMS councils and the Department will assist any service experiencing difficulty retaining a physician. Also, beginning in Fiscal Year 2012-2013, the Department included the cost of employing a medical director, at a maximum of $10,000 per year, as an allowable reimbursable cost under EMSOF.

There will be additional costs to the regulated community to comply with the requirement that an EMS agency be operational 24 hours a day, 7 days a week. However, this requirement is in the EMS System Act and not created by regulation. Again, the Department is unable to calculate those costs with certainty because they will vary greatly depending on the part of this Commonwealth in which the EMS agency operates. In more densely populated areas, an EMS agency will need a larger staff of EMS providers to be operational 24 hours a day, 7 days a week. In less densely populated areas, an EMS agency may not need a larger staff to meet this requirement, as it may not service as many patients as an EMS agency in a more densely populated area. However, the EMS System Act and final-form § 1027.6 (relating to Statewide EMS response plan) (proposed § 1027.5) provide for exceptions to the full-time operation requirement. The EMS agency also may partner with other EMS providers and enter into a county-level or broader-level EMS response plan under final-form § 1027.6. Either alternative would enable an EMS agency to operate and not incur costs connected with offering service 24 hours a day, 7 days a week.

On average, a basic EMS provider is paid about $12 per hour and an advanced EMS provider is paid about $18 per hour. However, the Department cannot calculate staffing costs for an EMS agency because the Department cannot know how many EMS providers an EMS agency will need to meet the requirement that the EMS agency is operational 24 hours a day, 7 days a week.

Dispatch centers, if operated by an EMS agency, will be subject to the Department's regulations that include training and certification requirements for the dispatch center staff. The Department consulted with the Pennsylvania Emergency Management Agency (PEMA) for guidance on training and recertification costs for call-takers and dispatchers. Section 8129(i)(1) of the EMS System Act requires an EMS agency that operates an EMS agency dispatch center to use call-takers and dispatchers who satisfy PEMA's requirements under 35 Pa.C.S. § 5303(a)(6) (relating to telecommunications management). The initial emergency medical dispatcher (EMD) certification requires the applicant to be able to read and write at a high school graduate or GED level and complete an approved EMD course in which the applicant completes a written certification exam and obtains a passing score. The EMD course is approximately 24 to 40 hours in length with a cost of approximately $200, depending on which Nationally-recognized program the EMS agency uses. Once the call-taker or dispatcher passes an EMD course, PEMA will provide the applicant with an additional Commonwealth EMD test. There is not an additional cost to the EMS agency or the applicant for this test. The applicant must also be certified in CPR. To complete a CPR course will cost approximately $35, depending on which program the EMS agency uses. The Department estimates, however, that fewer than ten EMS agencies will confront these costs as most EMS agencies are using the county dispatch centers for their emergency responses instead of their own EMS agency dispatch centers. These figures have been added to the fiscal table in the RAF.

As for costs or savings to local governments associated with compliance with these regulations, there would not be appreciable additional costs or savings to local government. Some regional EMS councils are a part of county government; however, they will be performing essentially the same work under the EMS System Act and regulations as they have been performing under the prior EMS Act.

As for costs or savings to State government associated with implementation of these regulations, there is an increase in costs to the Department associated with its new statutory duty to license and certify EMS providers and other persons and entities involved in the EMS system. Under the EMS System Act and these regulations, the Department is required to issue new certifications and registrations for EMSVOs, EMRs, AEMTs, prehospital physician extenders (PHPE), medical command physicians and medical command facility medical directors. The Department is also required to develop additional patches and decals to recognize the new levels of certification. The estimated cost to the Department is $1,500 per new type of EMS provider certification, approximately $6,000 total. The Department will manage this cost within the Bureau's annual budget.

These regulations also will require enhancement to the EMS Registry System (EMSRS) software and Agency Application System (AAS) software. Enhancements to both systems will be combined with required improvements to the EMSRS and AAS to meet National standards for EMS credentialing. System enhancements will be accomplished using one staff person whose salary is funded from Federal grants through the Department's Bureau of Public Health Preparedness.

The Department's disciplinary authority has been expanded under the EMS System Act and it now has the ability to impose civil money penalties. Depending upon the type of entity upon which the civil money penalty is imposed, penalties can range from $1,000 to $5,000 per finable violation. Revenue generated based on civil money penalties is estimated to reach $10,000 per year.

Savings will be realized in the contract or grant award process because the Department will not be required to devote staff time every 3 years to justify sole source contracting with regional EMS councils. Section 8112(l) of the EMS System Act permits the Department to renew a contract or grant with a regional EMS council without engaging in competitive bidding if the regional EMS council, in performing its duties under the prior grant or contract, demonstrated to the Department's satisfaction its ability and commitment to meet its responsibilities under that grant or contract.

The Department will also save certain costs previously associated with recertification of an EMS provider. Various provisions of the EMS System Act require an applicant for EMS provider or EMSVO certification to report to the Department misdemeanors, felonies and other criminal convictions that are not summary or equivalent offenses, and disciplinary sanctions that have been imposed upon a license, certification or other authorization of the applicant to practice an occupation or profession. An applicant for an EMSVO certification is to report to the Department any other conviction of an offense involving reckless driving, driving under the influence of alcohol or drugs or a conviction that resulted in the suspension of the applicant's driver's license due to the use of drugs or alcohol, or a moving traffic violation. The regulations require the applicant also to arrange for the custodian of the criminal charging, judgment and sentencing document for each conviction and the custodian of an adjudication or other document imposing discipline against the applicant to provide the Department with a certified copy of those records. Requiring the applicant to provide these records will save the Department the cost and time to request and receive the required documents.

The Department will save costs associated with the process under the prior EMS Act permitting EMS providers to appeal to the Department a loss of medical command authorization. The EMS System Act and the regulations require a medical director of an EMS agency to conduct an initial and annual assessment of each EMS provider of the EMS agency at or above the AEMT level, and to determine whether to allow the EMS provider to perform skills at the level at which the provider is certified. Once this credentialing determination, called a medical command authorization decision, is completed, an appeal of the EMS agency medical director's decision to the Department was not authorized. Under the prior EMS Act, an adverse medical command authorization decision could be appealed to the regional EMS medical director. That decision could be appealed to the Department and then to Commonwealth Court. This appeal process imposed costs on the affected EMS provider, the medical director who made the decision, the regional EMS council and the Department. The EMS System Act eliminates that appeal process and the associated costs.

Requests for and Changes to Sections of the Final-Form Rulemaking

Following publication of the proposed rulemaking, the Department realized that sections of the regulations describing BLS squad services, intermediate ALS ambulance services and intermediate ALS squad services which should have been included in Chapter 1027, Subchapter B (relating to EMS agency services) were inadvertently omitted when the proposed rulemaking was submitted for publication. A section describing and listing staffing and other requirements applicable to an intermediate ALS ambulance service has been added in final-form § 1027.34. A section describing and listing staffing and other requirements applicable to a BLS squad service has been added in final-form § 1027.36 (relating to basic life support squad service). A section describing and listing staffing and other requirements applicable to an intermediate ALS squad service has been added in final-form § 1027.37. The other sections in Chapter 1027, Subchapter B were renumbered accordingly.

On its own initiative, the Department simplified § 1027.33(d), final-form § 1027.35(c) and final-form § 1027.38(c) (relating to advanced life support squad service) identifying procedures to be implemented when multiple EMS providers are present at the same scene. The changes were made to ensure consistency with similar language used in other sections in Chapter 1027, Subchapter B.

Subpart A. EMS system

This final-form rulemaking amends the heading of Subpart A from ''EMS systems'' to ''EMS system.'' The Commonwealth's EMS system is one unified Statewide system as opposed to multiple systems.

§ 1021.2. Definitions

Comment

IRRC noted that there were not definitions for ''911 system'' or ''specialty services,'' as those terms are used in § 1021.24(a)(1)(i) and (ii), respectively. IRRC further noted it believes the addition of definitions for those terms would improve the clarity of the regulations and assist the regulated community with compliance.

Response

The Department considered this comment and determined that ''911 system'' and ''specialty services'' should be deleted from final-form § 1021.24(a)(1)(i) and (ii). Therefore, definitions are not necessary. ''Specialty services'' was a general term and it was meant to serve as an example of public awareness programs for regional EMS councils for EMSOF funding. The Department also deleted the examples given in this section, ''first aid'' and ''CPR,'' to make this section more general in scope.

If the Department were to add a definition for ''911 system,'' the Department would likely look to the definition as provided by PEMA in 35 Pa.C.S. §§ 5301—5398 (relating to emergency telephone service). If that definition were incorporated in this regulation, the Department would need to define ''enhanced 911 service'' and ''wireless E-911 system'' because those words are included in the definition of ''911 system.'' These terms are not needed as they are not used in the Department's regulations. Therefore, the Department replaced ''911 system'' in § 1021.24(a)(1)(i) with ''call-taking'' and ''dispatching,'' terms that are defined in the Department's regulations and deal more closely with the Department's oversight of EMS agency dispatch centers.

Comment

IRRC noted that the regulatory definition of ''ambulance'' differed from the definition of ''ambulance'' in section 8103 of the EMS System Act. IRRC noted that unlike the statutory definition, the regulatory definition in proposed § 1021.2 (relating to definitions) did not include the term ''water vehicle.''

Response

The Department agrees that the regulatory definition should match the statutory definition. Therefore, the regulatory definition of ''ambulance'' has been revised to match the statutory definition.

Comment

A commentator questioned the definition of ''facility,'' which is defined as ''a physical location at which an entity operates a health care facility licensed under Federal or State law.'' The commentator thought the definition was vague and questioned the reference within the definition to licensure under Federal law, although the commentator believed that hospitals within the Veteran's Administration might be licensed under Federal law. The commentator was also concerned that the definition could be interpreted to exclude a psychiatric hospital as a receiving facility in an emergency situation, even though a psychiatric hospital could well be the appropriate receiving facility, depending on the nature of the illness of the individual.

Response

The Department did not change the definition of ''facility'' in response to this comment. The definition of ''facility'' mirrors the definition of ''facility'' in section 8103 of the EMS System Act. The Department can expand upon a statutory definition in a regulation but cannot change it. The commentator is correct. A Veteran's Administration facility is licensed under Federal law and is, therefore, a ''facility'' under the EMS System Act. A psychiatric facility is licensed under State law and is, therefore, a ''facility'' under the EMS System Act. It is also a ''receiving facility'' because it is ''a facility to which an ambulance may transport a patient who requires prompt medical care in addition to that provided by EMS providers who respond to an emergency.''

Comment

A commentator suggested that ''hospital'' should be defined in a manner consistent with the Health Care Facilities Act (HCFA) (35 P. S. §§ 448.101—448.904b). The commentator was concerned that while the first sentence of the definition of ''hospital'' is consistent with the definition for ''hospital'' in the HCFA, the second sentence of the definition in § 1021.2 is unclear and does not appear to be consistent with the definition of ''hospital'' in statute or other regulations.

Response

The Department did not change the definition of ''hospital.'' The Department compared the definition of ''hospital'' in the HCFA to the definition of ''hospital'' in the EMS System Act (as the definition of ''hospital'' in the EMS System Act forms the basis for the definition of ''hospital'' in § 1021.2), paying particularly close attention to the second sentence of the definition, per the suggestion of the commentator. In section 8103 of the EMS System Act, the second sentence of the definition for ''hospital'' states ''The term includes a facility for the diagnosis and treatment of disorders within the scope of specific medical specialties. The term does not include a facility caring exclusively for the mentally ill.'' In section 802.1 of the HCFA (35 P. S. § 448.802a), the second sentence of the definition for ''hospital'' states ''The term includes facilities for the diagnosis and treatment of disorders within the scope of specific medical specialties, but not facilities caring exclusively for the mentally ill.'' The definitions are virtually identical; therefore, a change to § 1021.2 is not required.

Comment

IRRC noted that ''medical command'' was not defined. As this term is used throughout the regulations, IRRC commented that a definition for this term would improve the clarity of the regulations and assist the regulated community with compliance.

Response

The Department agrees and added the definition of ''medical command'' in the final-form rulemaking. The definition is modeled after the definition of ''medical command'' in former § 1001.2. In addition, the Department deleted the definition of ''medical command order'' from the final-form rulemaking. With the addition of the more specific term ''medical command,'' which includes orders given by a medical command physician, ''medical command order'' was superfluous. References to ''medical command order'' in the regulations have been replaced with ''medical command.''

Comment

IRRC commented on the Department's proposed definition of ''PSAP—public safety answering point.'' IRRC was concerned that the Department's definition contained substantive requirements that are not appropriate for definitions.

Response

The Department agrees with IRRC's comment. The Department revised this definition to mirror the definition in 35 Pa.C.S. § 5302 (relating to definitions).

Comment

IRRC commented on the Department's definition of ''specialty receiving facility.'' IRRC requested clarification on the process the Department will use to make this designation and whether this process is in a regulation. IRRC also requested clarification regarding whether a facility would have to request this designation from the Department and how the regulated community would know if a facility had been identified as a ''specialty receiving facility.''

Response

The Department deleted the definition of ''specialty receiving facility'' because the reference to specialty receiving facilities in § 1029.21(b) was deleted. With the deletion of ''specialty receiving facilities'' from § 1029.21(b), a definition is no longer required. The Department will continue to consider issues surrounding specialty receiving facilities and will, if necessary, reintroduce this concept and provide a definition in a future rulemaking.

Department-initiated changes for § 1021.2

The Department added definitions of ''ambulance crew'' and ''EMS vehicle crew'' since those terms are used throughout Chapter 1027 (relating to EMS agencies). The only difference between the two terms is that an ''ambulance crew'' refers to staff of an ambulance only, while the term ''EMS vehicle crew'' refers to staff of any EMS vehicle.

The Department revised the definition of ''EMS—emergency medical services'' to mirror the definition in section 8103 of the EMS System Act.

The Department revised the definition of ''EMS agency—emergency medical services agency'' to include a BLS water ambulance, an intermediate ALS water ambulance, an ALS water ambulance and an EMS agency dispatch center. The Department also reordered the list to match the order of other lists in the regulations.

The Department revised the definition of ''EMS vehicle—emergency medical services vehicle'' to include a water ambulance.

The Department revised the definition of ''medical command facility'' to mirror the definition in section 8103 of the EMS System Act.

The Department revised subparagraph (iii) of the definition of ''medical coordination'' to clarify that medical coordination includes medical command physicians giving medical command to EMS providers. The Department also revised this definition to ensure parallel construction of each of the numbered clauses.

The Department added a definition of ''water ambulance.''

§ 1021.41. EMS patient care reports

Comment

A commentator noted that § 1021.41 does not require a medication and intervention report to be submitted during the transfer of the patient to the care of the receiving facility and suggested that a report should be required.

Response

The Department did not change § 1021.41 in response to this comment as the Department requires medication and intervention information to be submitted by the EMS provider to the receiving facility. Section 1021.41 states the Department will specify the types of patient information that are essential for immediate transmission for patient care by publishing a notice in the Pennsylvania Bulletin. The authority for publication of certain types of patient information is in section 8106(f) of the EMS System Act.

In the notice published in the Pennsylvania Bulletin currently, the Department requires an ambulance service to provide to the person at the hospital assuming responsibility for the patient the patient information designated in the PCR as essential for patient care, regardless whether the EMS provider is able to provide all of the information solicited by the EMS PCR. A separate medication and intervention report as requested by the commentator is not needed because the report that is already required under § 1021.41 elicits the necessary information. This information includes medication and intervention information such as: procedures; medications given; gender; age; condition code number; chief complaint; chief complaint organ system; primary symptom; provider's primary impression; cause of injury; vehicular injury indicators; first monitored rhythm of the patient; medication allergies; current medications; blood pressure; pulse rate; respiratory rate; medication given; and medication dosage.

Department-initiated changes for § 1021.41

Proposed § 1021.41(a) required the EMS agency to submit an EMS PCR report to the regional EMS council that is assigned responsibility for the region in which the EMS agency initially encounters the patient. In reviewing this section, the Department realized that this requirement would cause problems for EMS agencies that encounter patients outside of the region in which they typically operate. EMS agencies are often asked to treat a patient outside of the region in which they operate because of the unavailability of EMS agencies within a particular region, inadequate staffing or an emergency situation in which multiple EMS agencies are needed to respond, for example. Based on the wording of the proposed subsection, depending on the emergency scenario, an EMS agency would have been required to submit EMS PCR reports to multiple regions, causing undue hardship and unnecessary confusion for EMS agencies. The Department revised this subsection to require EMS PCR reports to be filed with the regional EMS council in which the EMS agency is licensed to operate. This revision maintains the requirements for ambulance services under former § 1001.41(a). While this revision will ease the burden on EMS agencies, the Department recognizes that the regional EMS council where the patient was initially encountered still has an interest in reviewing EMS PCR reports that were generated by patient care that occurred within that particular EMS region. Therefore, the Department added a second provision to this subsection that allows the regional EMS council where the patient was initially encountered to request a copy of the EMS PCR report from the EMS agency that treated the patient. Regional EMS councils may want to review these reports for quality assurance purposes, training purposes or pursuant to an investigation or complaint request. Requesting the report from the EMS agency is not a requirement and is purely voluntary for the regional EMS council where the patient was initially encountered. Regional EMS councils can decide which EMS PCR reports they need to review.

The Department also revised § 1021.41(d) to clarify that the EMS provider who has assumed primary responsibility for the patient is required to complete an EMS PCR for that patient. As proposed, this subsection required each EMS agency to have a policy for designating which member of the responder crew would be responsible for completing the EMS PCR form. The Department felt that it would be better to have a uniform policy concerning the person who is responsible for filling out the EMS PCR form, as this will eliminate any confusion that may arise as to who should complete the form.

Department-initiated changes to § 1021.42

The Department revised § 1021.42(a)(6) by deleting the slash mark between ''entry'' and ''retrieval'' and by adding ''data'' before ''retrieval.''

§ 1021.61. Components of Statewide quality improvement program

Comment

A commentator suggested that health care facilities, specifically hospitals, should have input in the Statewide EMS quality improvement program. The commentator believed that seeking input from EMS agencies and health care facilities, including hospitals that serve as receiving facilities, is an important part of the Statewide EMS quality improvement program. IRRC noted the commentator's comment in its comments to the Department.

Response

The Department did not change § 1021.61 (relating to components of Statewide quality improvement program) in response to this comment as the EMS System Act already provides for input from organizations that represent hospital administrators and other health care providers concerned with EMS. Section 1021.61 provides for the Advisory Board to work in conjunction with the Department to identify the necessary components for a Statewide quality improvement program for the Statewide EMS system. The Advisory Board is authorized under section 8108(b)(2) of the EMS System Act (relating to State Advisory Board) to ''advise the department concerning manpower and training, communications, EMS agencies, content of regulations, standards and policies promulgated by the department under this chapter and other subjects deemed appropriate by the department.'' In addition, under section 8108(b)(3) of the EMS System Act the Advisory Board is to ''serve as the forum for discussion on the content of the Statewide EMS system plan, or any proposed revisions thereto, and advise the department as to the content of the plan.''

The Advisory Board is required under section 8108(a) of the EMS System Act to be geographically representative of the provider organizations that represent EMS providers, firefighters, regional EMS councils, physicians, hospital administrators and other health care providers concerned with EMS. Therefore, hospital administrators and other health care providers have a voice through provider organizations that serve on the Advisory Board and one of the main functions of the Advisory Board is to discuss and propose revisions to the Statewide EMS system plan.

For Fiscal Year 2011-2012, the Board of Directors of the Advisory Board was comprised of several hospital and health care organizations, including representatives for the Hershey Medical Center, the Hospital & Healthcare Association of Pennsylvania, UPMC Presbyterian and York Hospital. See http://www.pehsc.org/board_members.htm. Hospital and health care organizations play an active role in the development of the Statewide EMS system plan through their representation on the Advisory Board.

The Department has not changed § 1021.62 in response to this comment. Regional EMS councils shall conduct an audit of the regional EMS systems per the terms of the grants that are entered into between the Department and the individual regional EMS councils. Currently, regional quality improvement committees must meet every 90 days and then have 30 days to submit a report to the Department.

The Department needs the flexibility to be able to negotiate changes to the terms of the grants as circumstances warrant to better protect the general public. This section merely puts entities on notice that quality improvement audits will be required of any regional EMS council. The grant specifies the time frames when the requirements must be met. If the Department were to codify audit requirements, the Department would not be able to act quickly to make changes to the audit process as the Department deems necessary.

Comment

IRRC also commented on § 1021.62(5). This paragraph states that regional EMS councils shall submit to the Department reports as prescribed by the Department. IRRC is concerned that this paragraph is vague and that the Department should enhance it or delete it.

Response

The Department agrees with this comment and deleted § 1021.62(5). Reporting responsibilities for regional EMS councils are in the grants entered into between the Department and each regional EMS council. Regional EMS councils are apprised by the grant agreement the reports that they are required to submit to the Department and the information that is required to be in those reports. Therefore, the paragraph is not necessary.

§ 1021.82. Requirements

Comment

A commentator questioned the requirement in this section requiring trauma centers to have a dedicated telephone number. The commentator noted that this requirement is already in the trauma center regulations.

Response

The commentator did not specify nor cite to the regulations referred to in the comment. Therefore, the Department can only surmise that the commentator is referring to the Pennsylvania Trauma Systems Foundation's (Trauma Foundation) standards for trauma center accreditation. These standards require a formal consultation process, identified by the institution, to ensure appropriate 24-hour telephone consultation for levels I and II adult and pediatric trauma centers. This process must provide access to the appropriate physician, subspecialty or allied health professional and assist with clinical triage or patient transfer, or both, when necessary. See 2012 Standards for Trauma Center Accreditation, Adult or Pediatric Levels I, II, and III at www.ptsf.org.

Section 1021.82(1) (relating to requirements) requires trauma centers to maintain a dedicated telephone number for communication between the trauma center and a transferring hospital. The Department believes that a dedicated telephone number is important to ensure that trauma centers are integrated into the Statewide EMS system. The requirement for a dedicated telephone number for trauma centers has been a part of the EMS regulations since the first set of regulations was promulgated under the prior EMS Act. See 19 Pa.B. 2859, 2860. That a Trauma Foundation standard contains a similar requirement is not a reason to revise the requirement in this regulation. The Department does not have authority to enforce Trauma Foundation standards. Moreover, the Trauma Foundation could revise or eliminate this particular standard. The EMS System Act did not grant the Department the authority to enforce third-party standards so the Department must codify its own standards to effectuate its responsibilities under the EMS System Act.

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